Cure Dextra

GUDID 00815947021243

Closed System Single Urinary Catheterization System, Straight Tip

CURE MEDICAL LLC

Single-administration urethral drainage catheter

• Primary Device ID: 00815947021243
• NIH Device Record Key: 6a11cfc5-f235-4be3-a26e-8b979247bee7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cure Dextra
• Version Model Number: DEX12
• Company DUNS: 070643426
• Company Name: CURE MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com

Device Dimensions

• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815947021243 [Primary]
GS1	10815947021240 [Package]; Package: Case [90 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080881

FDA Product Code

• KOD: Catheter, Urological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-07
• Device Publish Date: 2020-08-28

On-Brand Devices [Cure Dextra]

• 10815947021271: Closed System Single Urinary Catheterization System, Straight Tip
• 10815947021264: Closed System Single Urinary Catheterization System, Straight Tip
• 10815947021257: Closed System Single Urinary Catheterization System, Straight Tip
• 00815947021243: Closed System Single Urinary Catheterization System, Straight Tip
• 00815947021236: Closed System Single Urinary Catheterization System, Straight Tip